Frequently Asked Questions About the
OPDIVO® (nivolumab) + YERVOY® (ipilimumab) Combination
Here are some frequently asked questions and answers that patients like you have had
about treatment with OPDIVO + YERVOY. Remember that this information is not a
substitute for talking with your healthcare professional. Your healthcare professional is the
best source of information about your condition.
HOW IS THE OPDIVO + YERVOY COMBINATION DIFFERENT FROM OTHER TREATMENTS?
The OPDIVO + YERVOY combination is not traditional chemotherapy. It is a powerful combination therapy that works with your immune system to fight cancer. The OPDIVO + YERVOY combination brings together 2 metastatic treatments that work together in complementary ways. It unites the breakthrough advancement of OPDIVO, a PD-1 (programmed death receptor-1) immunotherapy, with the established history of YERVOY. Chemotherapy, on the other hand, uses different drugs to kill or slow the growth of fast-growing cells, including cancer cells.
While doing so, OPDIVO and YERVOY could also affect non-tumor cells. Because of the way the OPDIVO + YERVOY combination works, it may cause your immune system to attack normal organs and tissues in your body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment ends.
WHY SHOULD MY DOCTOR AND I CONSIDER THE OPDIVO + YERVOY COMBINATION?
Deciding on how you will fight metastatic melanoma is one of the most important decisions you and your oncologist will make. OPDIVO + YERVOY received approval from the FDA because of the overall survival data (the percentage of patients with advanced melanoma who were alive during the clinical trial compared to those who received YERVOY alone). For more information, see the Clinical Trial Results.
In a clinical trial of 945 previously untreated patients, 314 took OPDIVO + YERVOY, 316 took OPDIVO alone and 315 took YERVOY alone. In a follow-up analysis for this trial at four years, 53% of people treated with OPDIVO + YERVOY were alive at four years compared to 30% of patients on YERVOY who were alive at 4 years. The follow-up analysis at four years is consistent with the earlier (primary) analysis at 28 months. At 28 months, OPDIVO + YERVOY reduced the risk of dying by 45% compared to YERVOY alone. Half the patients on YERVOY were alive at 19.9 months, compared to more than half being alive with OPDIVO + YERVOY.
The OPDIVO + YERVOY combination will not work for every patient. Individual results may vary. So talk to your oncologist to see if the combination is right for you.
See the results for patients treated with OPDIVO alone here.
HOW MANY PEOPLE PARTICIPATED IN THIS CLINICAL TRIAL?
The clinical trial included 945 adult patients with unresectable or metastatic melanoma who were previously untreated. Patients were treated with either the combination of OPDIVO + YERVOY, OPDIVO alone, or YERVOY alone.
CAN I BE PRESCRIBED THE OPDIVO + YERVOY COMBINATION REGARDLESS OF BRAF STATUS?
WHERE CAN I GO TO GET MY OPDIVO + YERVOY TREATMENTS?
You and your doctor should discuss the best place to get your infusions, whether it’s your doctor’s office, an infusion center, or a local hospital.
HOW DO I KNOW IF I’M RESPONDING TO THE OPDIVO + YERVOY COMBINATION?
While undergoing treatment with the OPDIVO + YERVOY combination, your doctor will likely order periodic scans to evaluate whether there are any changes in the size of your tumors.
WHAT SHOULD I KNOW ABOUT POTENTIAL SIDE EFFECTS?
Some of the side effects of the OPDIVO + YERVOY combination may be life-threatening and may need your doctor’s immediate attention. Be sure to tell your doctor about all side effects as soon as possible, including any changes in how you are feeling, so he or she can help address them right away. OPDIVO can cause severe infusion reactions. Tell your doctor or nurse right away if you get these symptoms during an infusion of OPDIVO: chills or shaking; itching or rash; flushing; difficulty breathing; dizziness; fever; feeling like passing out.
What are the most common side effects of OPDIVO when used in combination
The most common side effects of OPDIVO, when used in combination with YERVOY, include: feeling tired; rash; diarrhea; nausea; fever; pain in muscles, bones, and joints; upper respiratory tract infection; itching; abdominal pain; vomiting; cough; decreased appetite; and shortness of breath. The most common side effects of YERVOY include: feeling tired; diarrhea; nausea; itching; rash; vomiting; headache; weight loss; fever; decreased appetite; and difficulty falling or staying asleep.
What are the serious side effects of OPDIVO when used in combination with YERVOY?
OPDIVO can cause problems that can sometimes become serious or
- lung problems (pneumonitis)
- intestinal problems (colitis) that can lead to tears or holes in your intestine
- liver problems (hepatitis)
- hormone gland problems (especially the thyroid, pituitary, adrenal glands, and pancreas )
- kidney problems, including nephritis and kidney failure
- skin problems
- inflammation of the brain (encephalitis)
- problems in other organs
- severe infusion reactions
Additional serious side effects observed during a separate study of YERVOY alone include:
- nerve problems that can lead to paralysis
- eye problems
WHAT SHOULD I TELL MY
Before you receive the OPDIVO + YERVOY combination, tell your healthcare
provider if you:
- Have immune system problems such as Crohn’s disease, ulcerative colitis, lupus, or sarcoidosis
- Have had an organ transplant
- Have lung or breathing problems
- Have any other medical conditions
- Are pregnant or plan to become pregnant
- - OPDIVO and YERVOY can harm your unborn baby
- - Females who are able to become pregnant should use an effective method of birth control during and for at least 5 months after the last dose of OPDIVO. Talk to your healthcare provider about birth control methods that you can use during this time.
- - Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment. You or your healthcare provider should contact Bristol-Myers Squibb at 1-800-721-5072 as soon as you become aware of the pregnancy.
- - Pregnancy Safety Surveillance Study: Females who become pregnant during treatment with YERVOY are encouraged to enroll in a Pregnancy Safety Surveillance Study. The purpose of this study is to collect information about the health of you and your baby. You or your healthcare provider can enroll in the Pregnancy Safety Surveillance Study by calling 1-844-593-7869.
- Are breastfeeding or plan to breastfeed
- - It is not known if either treatment passes into your breast milk
- - Do not breastfeed during treatment and for 3 months after the last dose of YERVOY
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
WHO CAN I TALK TO IF I NEED HELP OR HAVE QUESTIONS ABOUT OPDIVO + YERVOY?
Talk with your healthcare professional first if you have questions about this treatment option. You can also call a Care Navigator at 1-855-673-4861, 8 AM to 8 PM ET, Monday-Friday for general questions about the OPDIVO + YERVOY combination not specific to your health.
It can be helpful to review a list of questions you may want to ask
your doctor. Download Questions to Ask Your Doctor to help
answer your questions about whether OPDIVO + YERVOY may be
right for you.
See Clinical Trial Results
See how OPDIVO + YERVOY
performed in a clinical trial in patients.
Complimentary support, tools, and educational resources
for anyone considering or currently taking OPDIVO + YERVOY.
Call 1-855-OPDIVO-1 or click to
Talking With Your Doctor Is Key
Review a list of questions with your
oncologist about whether OPDIVO + YERVOY is right for you.